Biopsy Device with Sliding Cutter Cover

ABSTRACT

A biopsy device comprises a targeting set, a probe assembly, and a holster assembly, which are detachable from one another. The targeting set comprises a needle assembly having a tissue piercing tip and tissue receiving aperture. The probe assembly comprises a tissue cutter, a body, cutter driving mechanism components, and a sliding cutter cover. The cutter extends from a distal portion of the probe assembly. The sliding cutter cover extends from the distal portion of the probe assembly when the probe assembly is detached from the needle assembly of the targeting set assembly. This extension of the sliding cutter cover shields a user of the biopsy device from the sharp cutter. The sliding cutter cover further retracts into the probe assembly when the probe assembly is coupled with the needle assembly of the targeting set assembly. The cover may be resiliently biased to extend distally from the probe assembly.

Biopsy samples have been obtained in a variety of ways in variousmedical procedures using a variety of devices. Biopsy devices may beused under stereotactic guidance, ultrasound guidance, MRI guidance, PEMguidance, BSGI guidance, or otherwise. Merely exemplary biopsy devicesare disclosed in U.S. Pat. No. 5,526,822, entitled “Method and Apparatusfor Automated Biopsy and Collection of Soft Tissue,” issued Jun. 18,1996; U.S. Pat. No. 6,086,544, entitled “Control Apparatus for anAutomated Surgical Biopsy Device,” issued Jul. 11, 2000; U.S. Pub. No.2003/0109803, entitled “MRI Compatible Surgical Biopsy Device,”published Jun. 12, 2003; U.S. Pub. No. 2007/0118048, entitled “RemoteThumbwheel for a Surgical Biopsy Device,” published May 24, 2007; U.S.Pub. No. 2008/0214955, entitled “Presentation of Biopsy Sample by BiopsyDevice,” published Sep. 4, 2008; U.S. Provisional Patent ApplicationSer. No. 60/869,736, entitled “Biopsy System,” filed Dec. 13, 2006; andU.S. Provisional Patent Application Ser. No. 60/874,792, entitled“Biopsy Sample Storage,” filed Dec. 13, 2006. The disclosure of each ofthe above-cited U.S. Patents, U.S. Patent Application Publications, andU.S. Provisional Patent Applications is incorporated by referenceherein.

BACKGROUND

Some biopsy systems may provide a probe assembly having an attachedneedle. Such biopsy systems may also be used with a cannula andobturator, which are used to create the channel through the tissue to adesired biopsy site. In some such biopsy systems, the obturator may beremoved once the cannula is positioned, and the needle of the probeassembly may be inserted through the cannula to reach the biopsy site.The tissue sample may then be pulled through aligning apertures in thecannula and needle into an axial lumen of the needle. A cutter may thentravel through the axial lumen to sever the tissue sample. In somesituations, it might be desirable to eliminate one or more of thecomponents that enter the patient's tissue during a biopsy procedure.One situation may be to eliminate the outer cannula by using a biopsysystem having a probe assembly, including a cutter, and a separatetargeting set assembly, including a needle. Once the targeting setassembly is positioned—with needle adjacent to the targeted tissue—theprobe assembly may be attached to the targeting set assembly forsevering and removing the targeted tissue.

While several systems and methods have been made and used for obtaininga biopsy sample, it is believed that no one prior to the inventors hasmade or used the invention described in the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

While the specification concludes with claims which particularly pointout and distinctly claim the invention, it is believed the presentinvention will be better understood from the following description ofcertain examples taken in conjunction with the accompanying drawings. Inthe drawings, like numerals represent like elements throughout theseveral views.

FIG. 1 depicts a perspective view of an exemplary MRI biopsy deviceshowing a holster assembly, probe assembly, and targeting set assembly.

FIG. 2 depicts a perspective view of the MRI biopsy device of FIG. 1,with the probe casing and locking cover removed to show a retractedsliding cutter cover.

FIG. 3 depicts a partially exploded perspective view of the probeassembly and holster assembly of the MRI biopsy device of FIG. 1,showing the sliding cutter cover extended.

FIG. 4 depicts a perspective, cross-sectional view of the probe assemblyand holster assembly of the MRI biopsy device of FIG. 1.

FIG. 5 depicts a perspective view of the probe assembly and holsterassembly of the MRI biopsy device of FIG. 1, showing the probe assemblyseparate from the holster assembly, and having the holster plate removedto expose internal components of the holster assembly, and the probecasing and locking cover removed to expose internal components of theprobe assembly.

FIG. 6 depicts a perspective view of the internal components of theprobe assembly and holster assembly of the MRI biopsy device of FIG. 1.

FIG. 7 depicts a perspective view of another exemplary MRI biopsy deviceshowing a holster assembly, probe assembly, and keypad.

FIG. 8 depicts a perspective view of the MRI biopsy device of FIG. 7,with the probe casing and keypad removed to show internal components ofthe probe assembly.

FIG. 9 depicts a cross-section view of the MRI biopsy device of FIG. 7.

FIG. 10 depicts a partially exploded perspective view of the MRI biopsydevice of FIG. 7.

FIG. 11 depicts a partial bottom view of the MRI biopsy device of FIG.7, showing internal components of the probe assembly and holsterassembly.

FIG. 12 depicts a perspective view of another exemplary MRI biopsydevice, showing a holster assembly, probe assembly, and targeting setassembly.

FIG. 13 depicts a partially exploded top view of the MRI biopsy deviceof FIG. 12, showing the holster assembly with holster plate removed,probe assembly, and targeting set assembly separate from one another.

FIG. 14 depicts a partially exploded bottom view of the MRI biopsydevice of FIG. 12, showing the holster assembly, probe assembly withprobe plate removed, and targeting set assembly separate from oneanother.

FIG. 15 depicts a perspective view of the probe assembly of FIG. 12,with the casing, annular ring, and keypad removed to show the vacuumtube and the cutter rotation and translation mechanism.

FIG. 16 depicts a partial perspective view of the cutter rotation andtranslation mechanism of the probe assembly of FIG. 12.

FIG. 17 depicts another partial perspective view of the cutter rotationand translation mechanism of the probe assembly of FIG. 12.

FIG. 18 depicts a section view of the cutter rotation and translationmechanism of the probe assembly of FIG. 12.

FIG. 19 depicts a partial side view of the rear portion of the cutterrotation and translation mechanism of the probe assembly of FIG. 12,showing the lead screw nut, encoder drive gear, and cutter driver withprojecting pin.

FIG. 20 depicts a perspective view of the holster assembly of FIG. 12,with the holster plate removed.

FIG. 21 depicts a rear view of the holster assembly of FIG. 12, with theholster plate removed.

FIG. 22 depicts a perspective view of an exemplary detachable needleassembly of a MRI biopsy device, showing a cradle assembly, needleassembly, and sleeve mount.

FIG. 23 depicts a perspective view of the needle assembly of FIG. 22.

FIG. 24 depicts an exploded view of the needle assembly of FIG. 22.

FIG. 25 depicts a cross-sectional view of the needle assembly of FIG.22.

FIG. 26 depicts a partial perspective view of the proximal end of theneedle assembly of FIG. 22, with the telescopic sleeve and telescopicsleeve spring removed.

FIG. 27 depicts a cross-sectional view of the proximal end of the needleassembly of FIG. 22, with the telescopic sleeve removed.

FIG. 28 depicts a perspective view of another exemplary detachableneedle assembly of a MRI biopsy device, showing a cradle assembly,needle assembly, and sleeve mount.

FIG. 29 depicts a top view of the needle assembly of FIG. 28.

FIG. 30 depicts an exploded view of the proximal end of the needleassembly of FIG. 28.

FIG. 31 depicts a partial perspective view of the proximal end of theneedle assembly of FIG. 28.

FIG. 32 depicts a cross-sectional view of the proximal end of the needleassembly of FIG. 28.

FIG. 33 depicts a perspective view of the proximal end of anotherexemplary needle assembly, having a sleeve cover with access openingsfor gear engagement.

FIG. 34 depicts a side view of the proximal end of the needle assemblyof FIG. 33, coupled with a probe assembly and showing gear engagement ofthe two assemblies.

FIG. 35 depicts a perspective view of the proximal end of anotherexemplary needle assembly, having a modified thumbwheel.

FIG. 36 depicts a partial perspective view of the thumbwheel of FIG. 35,showing a flexible membrane at the proximal-most end and a gear forindexing the needle.

FIG. 37 depicts a cross-sectional view of the thumbwheel of FIG. 35.

FIG. 38 depicts a perspective view, in partial transparency, of theneedle assembly of FIG. 35, coupled with a probe assembly, and showinggear engagement of the two assemblies.

FIG. 39 depicts a partial perspective view of the MRI biopsy device ofFIG. 1, showing the probe locking cover for attachment of the probeassembly to the needle assembly.

FIG. 40 depicts a partially exploded perspective view of the MRI biopsydevice of FIG. 39, showing the probe locking cover, pivot pin, andsprings.

FIG. 41 depicts a partial perspective view of the MRI biopsy device ofFIG. 39, showing engagement between the annular groove on the thumbwheeland an engaging member on the probe locking cover.

FIG. 42 depicts a cross-sectional view of the device of FIG. 39, showingengagement between the annular groove on the thumbwheel and an engagingmember on the probe locking cover.

FIG. 43 depicts a cross-sectional view of the device of FIG. 39, showingposition of the engaging member on the probe locking cover with respectto the annular groove on the thumbwheel when the probe assembly andneedle assembly are detached.

FIG. 44 depicts a partial perspective view of the MRI biopsy device ofFIG. 12, showing the annular ring and locking ring for attachment of theprobe assembly to the needle assembly.

FIG. 45 depicts a partial top view of the device of FIG. 44, showingengagement between the locking ring of the probe assembly and thumbwheelof the needle assembly.

FIG. 46 depicts a partial cross-section view of the device of FIG. 44,showing the engaged position of the locking members of the locking ringwith respect to the probe annular ring and the needle assemblythumbwheel.

FIG. 47 depicts a partial exploded perspective view of the device ofFIG. 44, showing the probe assembly detached from the needle assembly.

FIG. 48 depicts a perspective view of a proximal end of anotherexemplary needle assembly, having a snap connection for engaging athumbwheel.

FIG. 49 depicts a cross-sectional view of the needle assembly of FIG. 48coupled with a probe assembly, and showing engagement of the snapconnection to a thumbwheel.

FIG. 50 is a perspective view of another exemplary interface mechanismbetween a probe assembly and a needle assembly.

FIG. 51 depicts a top perspective view of the interface mechanism ofFIG. 50, showing engagement between the probe assembly and needleassembly.

FIG. 52 depicts another exemplary probe assembly, showing an interfacemechanism for attachment to a needle assembly as well as multipletelescopic cutter covers.

FIG. 53 depicts a perspective view of an exemplary cannula with anintegral blade.

FIG. 54 depicts a cross-sectional view of the cannula of FIG. 53.

FIG. 55 depicts a perspective view of the cannula of FIG. 53 coupledwith a modified biopsy probe needle.

FIG. 56 depicts a perspective view of the modified needle of FIG. 55.

FIG. 57 depicts a cross-sectional view of the cannula of FIG. 53 coupledwith the modified needle of FIG. 55.

FIG. 58 depicts a partial perspective view, in partial transparency, ofthe probe assembly of FIG. 12, showing fluid sealing and vacuum deliverymechanisms.

FIG. 59 depicts a cross-sectional view of the proximal end of the needleassembly shown in FIG. 28, attached to a probe assembly.

DETAILED DESCRIPTION

The following description of certain examples should not be used tolimit the scope of the present invention. Other examples, features,aspects, embodiments, and advantages of the invention will becomeapparent to those skilled in the art from the following description,which is by way of illustration, one of the best modes contemplated forcarrying out the invention. As will be realized, the invention iscapable of other different and obvious aspects, all without departingfrom the invention. Accordingly, the drawings and descriptions should beregarded as illustrative in nature and not restrictive.

I. Overview of Exemplary Biopsy System

FIGS. 1-59 show various components that may be incorporated into abiopsy system. By way of example only, a biopsy system may include abiopsy device (10, 12) and a vacuum control module (not shown). In someuses, biopsy device (10, 12) may be operated in a handheld fashion(e.g., under ultrasound imaging guidance). In some other uses, biopsydevice (10, 12) may be secured to a platform, table, or other fixture.For instance, a biopsy device (10, 12) may be used in combination withstereotactic or MRI imaging. In such uses, a biopsy device (10, 12) maybe secured to a targeting set, which may be used to position biopsydevice (10, 12) to specifically target a suspicious region of tissue(e.g., within a patient's breast or elsewhere). Examples of targetingset assemblies (22, 23) with biopsy devices (10, 12) are shown in FIGS.1-2 and 12-14, and will be described in greater detail below.

As will also be described in greater detail below, biopsy devices (10,12) shown in FIGS. 1, 7, and 12 comprise a probe assembly (14, 18, 19)and a holster assembly (16, 20, 21). In versions described herein, eachbiopsy device (10, 12) lacks an integral needle. Instead, a separateneedle assembly (28, 29, 30, 134, 160, 161) is removably coupled with atargeting set assembly (22, 23). Probe assembly (14, 18, 19) is operableto removably couple with such a needle assembly (28, 29, 30, 134, 160,161).

Needle assembly (28, 29, 30, 134, 160, 161) of the present examplecomprises a needle (42, 44, 64), which includes a tissue piercing tip(212), a transverse tissue receiving aperture (278), a lumen (82) forreceiving a cutter (106, 107), a lateral lumen (84) running parallelwith lumen (82), and openings (86) for providing fluid communicationfrom lateral lumen (84) to lumen (82). As will also be described ingreater detail below, probe assembly (14, 18, 19) includes cutter (106,107), which is configured to rotate and translate within lumen (82) whenprobe assembly (14, 18, 19) is coupled with needle assembly (28, 29, 30,134, 160, 161). For instance, when a distal portion of needle assembly(28, 29, 30, 134, 160, 161) is inserted into a patient's breast, tissuemay be drawn into aperture (278) under influence of a vacuum. Cutter(106, 107) may then simultaneously rotate and translate within lumen(82) to sever a tissue sample from such tissue protruding into aperture(278).

An exemplary vacuum control module may provide power (e.g., electrical,pneumatic, etc.), control signals, saline, vacuum, pressurized airand/or venting from the vacuum control module to biopsy device (10, 12).For instance, a vacuum control module may provide a vacuum to lumen (82)via one path; while providing a vacuum or venting to lateral lumen (84)via another path (e.g., a path that includes a manifold (97, 99, 101) ofprobe assembly (14, 18, 19), etc.). Examples of components, features,and methods of operating a vacuum control module are described in U.S.Pub. No. 2008/0195066, entitled “Revolving Tissue Sample Holder ForBiopsy Device,” published Aug. 14, 2008, the disclosure of which isincorporated by reference herein. In some versions, a vacuum controlmodule interface may be provided between biopsy device (10, 12) and thevacuum control module, such as the vacuum control module interfacedescribed in U.S. Non-Provisional patent application Ser. No. [FBTDOCKET NO. 0021680.END6466USNP], entitled “CONTROL MODULE INTERFACE,”filed on even date herewith, the disclosure of which is incorporated byreference herein.

II. Exemplary Targeting Set Assemblies

An exemplary targeting set assembly may be comprised of severalassemblies in combination. Such assemblies may include a stand assembly(24), cradle assembly (26, 32), and needle assembly (28, 29, 30, 134,160, 161). These assemblies will be discussed in greater detail in thesections that follow. However, it should be understood that a targetingset assembly may comprise a variety of other components in addition toor in lieu of any of the components described below. Other suitablecomponents, features, configurations, and methods of operating atargeting set assembly will be apparent to those of ordinary skill inthe art in view of the teachings herein.

A. Exemplary Stand and Cradle Assemblies

As shown in FIGS. 1, 12, 28, the targeting set assemblies (22, 23) ofthe present example include a stand assembly (24), a cradle assembly(26, 32), and a needle assembly (28, 29, 30, 134, 160, 161). By way ofexample only, stand assembly (24) may comprise a conventional stand thatis part of a breast biopsy MRI guidance system by Invivo Corp. ofOrlando, Fla. Of course, any other suitable type of stand assembly (24)may be used. Stand assembly (24) of the present example engages withcradle assembly (26), which further engages with needle assembly (28,29, 30, 134, 160, 161). Stand assembly (24) and cradle assembly (26) maybe adjustable to allow for positioning of needle assembly (28, 29, 30,134, 160, 161) at a desired location. For instance, stand assembly (24)may permit vertical adjustment of the cradle assembly (26), while cradleassembly (26) may permit horizontal adjustment or depth-of-insertion(a..k.a. z-depth) adjustment of needle assembly (28, 29, 30, 134, 160,161). Those of ordinary skill in the art will further appreciate thatrotational adjustment may be incorporated into stand assembly (24) andcradle assembly (26).

Suitable components of, features of, configurations of, and methods ofoperating stand assembly (24) and cradle assembly (26, 32), as well asways in which biopsy devices (10, 12) may be coupled with cradleassembly (26, 32), are described in further detail in U.S.Non-Provisional patent application Ser. No. [FBT DOCKET NO.0021680.END6474USNP], entitled “MUTLI-ORIENTATION TARGETING SET FOR MRIBIOPSY DEVICE,” filed on even date herewith, the disclosure of which isincorporated by reference herein. Of course, it will be appreciated inview of the disclosure herein that biopsy devices (10, 12) may be usedin a variety of other settings and combinations. For instance, as onemerely illustrative alternative, any of biopsy devices (10, 12) and/orneedle assemblies (28, 29, 30, 134, 160, 161) described herein may becoupled with a cube as described in U.S. Pub. No. 2007/0255170, entitled“BIOPSY CANNULA ADJUSTABLE DEPTH STOP,” published Nov. 1, 2007, thedisclosure of which is incorporated by reference herein. Exemplaryneedle assemblies (28, 29, 30), including those shown in FIGS. 1, 12,and 28, will be described in greater detail below.

B. Exemplary Needle Assemblies

As noted above, needle assembly (28, 29, 30, 134, 160, 161) of theexamples described below each comprises a needle (42, 44, 64), whichincludes a tissue piercing tip (212), a transverse tissue receivingaperture (278), a lumen (82) for receiving a cutter (106, 107), alateral lumen (84) running parallel with lumen (82), and openings (86)for providing fluid communication from lateral lumen (84) to lumen (82).Lumen (82) is configured to receive a cutter (106, 107) from a probeassembly (14, 18, 19) includes cutter (106, 107). For instance, when adistal portion of needle (42, 44, 64) is inserted into a patient'sbreast, tissue may be drawn into aperture (278) under influence of avacuum. Cutter (106, 107) may then simultaneously rotate and translatewithin lumen (82) to sever a tissue sample from such tissue protrudinginto aperture (278).

In some existing biopsy systems that are used in an MRI setting, atargeting cannula and obturator are used, which are separate from abiopsy device. The cannula has a transverse aperture, similar toaperture (278). For instance, in some uses of such systems, the cannulaand obturator are inserted into a patient's breast, and the transverseaperture of the cannula is positioned near a suspicious lesion. Suchpositioning of the transverse aperture of the cannula may be assisted byMRI imaging and targeting routines. The obturator may then be removedfrom the cannula, and the integral needle of a biopsy device may beinserted into the obturator. To the extent that the integral needle ofthe biopsy device also has a transverse aperture, that transverseaperture may be substantially aligned with the transverse aperture ofthe targeting cannula. A cutter in the biopsy device may then betranslated and rotated relative to both apertures to sever tissueprotruding therethrough. Examples of such biopsy systems are disclosedin U.S. Pub. No. 2005/0277829, entitled “MRI BIOPSY APPARATUSINCORPORATING A SLEEVE AND A MULTI-FUNCTION OBTURATOR,” published Dec.15, 2005, the disclosure of which is incorporated by reference herein;and U.S. Pub. No. 2007/0167736, entitled “MRI BIOPSY APPARATUSINCORPORATING AN IMAGEABLE PENETRATING PORTION,” published Jul. 19,2007, the disclosure of which is incorporated by reference herein.

It should be understood that, in some settings, examples of needleassembly (28, 29, 30, 134, 160, 161) described herein may eliminate theneed for having both a targeting cannula that is separate from a biopsydevice and a needle that is integral with the biopsy device forinsertion into the targeting cannula as described in theabove-referenced published U.S. patent applications. In other words, insome settings, examples of needle assembly (28, 29, 30, 134, 160, 161)described herein may provide combined functionalities of both thetargeting cannulas and the integral needles described in theabove-referenced published U.S. patent applications. For instance, adetachable needle assembly is described in U.S. Pub. No. 2003/0199785,entitled “LOCALIZATION MECHANISM FOR AN MRI COMPATIBLE BIOPSY DEVICE,”published Oct. 23, 2003, the disclosure of which is incorporated byreference herein. Some examples of needle assembly (28, 29, 30, 134,160, 161) described herein may also be used as a targeting cannula,separate from probe assembly (14, 18, 19), at initial stages ofoperation. Needle assembly (28, 29, 30, 134, 160, 161) may thus be usedwith an obturator (not shown) as described in the above-referencedpublished U.S. patent applications, to position aperture (278) nearsuspicious tissue. The obturator may then be removed, and a probeassembly (14, 18, 19) may be coupled with needle assembly (28, 29, 30,134, 160, 161) while needle (42, 44, 64) is still in the patient'sbreast (or other tissue area). Probe assembly (14, 18, 19) and needleassembly (28, 29, 30, 134, 160, 161) may then be used to acquire atissue sample as described herein.

While several needle assemblies (28, 29, 30) will be discussed ingreater detail below, it should be understood that the components,features, configurations, and methods of operation of needle assemblies(28, 29, 30) are not limited to the contexts provided below. Inparticular, components, features, configurations, and methods ofoperation described in the context of one of the exemplary needleassemblies (28, 29, 30) may be incorporated into any of the other needleassemblies (28, 29, 30). Furthermore, additional and alternativesuitable components, features, configurations, and methods of operationfor needle assemblies (28, 29, 30) will be apparent to those of ordinaryskill in the art in view of the teachings herein.

1. Exemplary Needle Assembly Mounting

When considering needle assembly (28, 29, 30, 134, 160, 161), one aspectto address may include modes for mounting needle assembly (28, 29, 30,134, 160, 161) to cradle assembly (26, 32). FIGS. 22 and 28 showexemplary needle assemblies (28, 30) coupled to exemplary cradleassemblies (26, 32). Cradle assemblies (26, 32) include a sleeve mount(34) as an exemplary mode of connecting needle assembly (28, 30) tocradle assembly (26, 32). For instance, in FIGS. 22 and 28, sleeve mount(34) provides one or more grooves or recesses at its proximal end forconnecting to a thumbwheel (36, 38) of needle assembly (28, 30).Thumbwheel (36, 38) comprises protrusions (46) along an interiorsurface, as shown in FIG. 27. Protrusions (46) engage the groove(s) orrecess(es) of sleeve mount (34) to create a removably secure connection,such as through a “snap fit.”

Sleeve mount (34) may further be configured to slide along a track (40)located on cradle assembly (26, 32) as shown in FIGS. 22 and 28. One ormore locking mechanisms (not shown), incorporated into cradle assembly(26, 32) and/or needle assembly (28, 30), may permit an operator toselectively lock the position of sleeve mount (34) at a desiredlongitudinal position along track (40). Such movement along track (40)and selective locking relative to track (40) may permit an operator toset needle assembly (28, 30) at a desired depth of insertion for needleassembly (28, 30) into a patient.

Additional ways in which a needle assembly (28, 29, 30, 134, 160, 161)may mount to a cradle assembly (26, 32), as well as other methods ofoperating the same, are disclosed in U.S. Non-Provisional patentapplication Ser. No. [FBT DOCKET NO. 0021680.END6474USNP], entitled“MUTLI-ORIENTATION TARGETING SET FOR MRI BIOPSY DEVICE,” filed on evendate herewith, the disclosure of which is incorporated by referenceherein. Of course, a needle assembly (28, 29, 30, 134, 160, 161) maymount to cradle assembly (26, 32) in any other suitable fashion, andneedle assembly (28, 29, 30, 134, 160, 161) may have any other suitablerelationship with cradle assembly (26, 32). Other suitablerelationships, mounting techniques, structures, and configurations willbe apparent to those of ordinary skill in the art in view of theteachings herein.

Another aspect to address when considering needle assembly (28, 29, 30,134, 160, 161) may include modes for mounting needle (42, 44) to needleassembly (28, 29, 30, 134, 160, 161). By way of example only, needle(42, 44) may engage with thumbwheel (36, 38) in a variety of ways tomake a suitable connection. For instance, as shown in FIGS. 24, 25, and27, needle (42) may comprise a proximal mounting portion (48), whichincludes projection members (50) and stopping members (52) near thedistal end. Proximal mounting portion (48) may be overmolded aboutneedle (42), such that proximal mounting portion (48) is unitarilysecured to needle (42). The orientation of projection members (50) andstopping members (52) create partial grooves (54) on both sides ofmounting portion (48) in this example. In a completed needle assembly(28), an interior lip and/or inward protrusions (not shown) on thedistal end of thumbwheel (36) engage with partial grooves (54) of themounting portion (48), providing “snap fit.” Projection members (50) andstopping members (52) thereby restrict further movement of thethumbwheel (36) with respect to the needle (42). Thumbwheel (36) andneedle (42) thus translate and rotate unitarily in this example.

In another exemplary needle (44) to thumbwheel (38) connection, as shownin FIGS. 30 and 32, needle (44) includes a locking tab (56) having astopper (58), and a mounting portion (60). Thumbwheel (38) includes anopening (62) to receive locking tab (56). Locking tab (56) is capable ofdeflecting to allow opening (62) of thumbwheel (38) to engage lockingtab (56). Mounting portion (60) is sized such that thumbwheel (38)cannot translate over mounting portion (60) in this example. In acompleted needle assembly (30), once thumbwheel (38) and needle (44) areengaged, stopper (58) of locking tab (56) and mounting portion (60)restrict further movement of thumbwheel (38) with respect to needle(44). Thumbwheel (38) and needle (44) thus translate and rotateunitarily in this example.

In another exemplary needle (64) to thumbwheel (66) connection, as shownin FIGS. 48 and 49, dual locking tabs (68) are shown. In thisarrangement, the proximal end of needle (64) includes a mounting portion(72) having dual locking tabs (68). A separate thumbwheel (66) ismounted on a probe assembly (65). Thumbwheel (66) includes dual openings(74) for engaging dual locking tabs (68) of mounting portion (72). Duallocking tabs (68) are capable of deflecting to allow dual openings (74)of the thumbwheel (66) to engage dual locking tabs (68). Once mountingportion (72) and thumbwheel (66) are engaged, stoppers (70) on duallocking tabs (68) restrict distal movement of the thumbwheel (66).Further proximal movement of the thumbwheel (66) is restricted by probeassembly (65). Thumbwheel (66) and needle (64) thus translate and rotateunitarily in this example.

Of course, a needle (42, 44, 64) may be incorporated into a needleassembly (28, 29, 30, 134, 160, 161) in any other suitable fashion, andneedle (42, 44, 64) may have any other suitable relationship with needleassembly (28, 29, 30, 134, 160, 161). Other suitable relationships,mounting techniques, structures, and configurations will be apparent tothose of ordinary skill in the art in view of the teachings herein.

2. Exemplary Needle Deflection Reduction

Another aspect to address when considering a detachable needle assembly(28, 29, 30, 134, 160, 161) may be minimizing needle deflection asneedle (42, 44, 64) is inserted into a patient, while maintainingimaging ability (e.g., under MRI, etc.). As shown in FIGS. 23 and 24,needle (42) of needle assembly (28) may include a first ceramic insert(76), a second ceramic insert (78), and an over-molded portion (80).Over-molded portion (80) may be a MRI compatible material, such as asuitable thermoplastic. Vectra® liquid crystal polymer is a commerciallyavailable example of a suitable over-molding material, available fromTicona, a company of Celanese Corporation. Other suitable materials andcombinations of materials will be apparent to those of ordinary skill inthe art in view of the teachings herein. First ceramic insert (76) islocated at the distal end of needle assembly (28) while second ceramicinsert (78) is located at the proximal end of needle assembly (28). Asshown in FIG. 25, over-molded portion (80) provides a needle assembly(28) having a dual lumen configuration with an axial lumen (82) and alateral lumen (84). First ceramic insert (76) includes holes (86) thatpermit communication between lateral lumen (84) and axial lumen (82).Alternatively, thermoplastic and ceramic components may be combined in avariety of other ways to provide a needle (42).

FIGS. 29, 30, and 32 show another exemplary needle (44) design for usein a needle assembly (30). Needle (44) includes a first ceramic insert(76) having holes (86) for communication between an axial lumen (82) anda lateral lumen (84). Needle (44) further includes an over-moldedportion (81) including a mounting portion (60) at the proximal end. Thesubstantial over-molded portion (81) in needle (44) may aid in reducingneedle deflection in some settings.

It should be understood that the above examples of needles (42, 44) aremerely illustrative. Needles (42, 44) may have any other suitablefeatures, components, or configurations to reduce deflection whilemaintaining imaging ability. Alternatively, needles (42, 44) may lackfeatures, components, or configurations to reduce deflection. Similarly,needles (42, 44) may be non-imageable if desired. By way of exampleonly, needles (42, 44, 46) may be configured in accordance with theteachings of U.S. Pub. No. 2008/0195066, entitled “Revolving TissueSample Holder For Biopsy Device,” published Aug. 14, 2008, thedisclosure of which is incorporated by reference herein. Other suitablefeatures, components, configurations, or properties for needles (42, 44,46) will be apparent to those of ordinary skill in the art in view ofthe teachings herein.

3. Exemplary Fluid Sealing and Vacuum Arrangement

With a detachable needle assembly (28, 29, 30, 134, 160, 161), anotheraspect to address may concern fluid sealing and vacuum arrangement.FIGS. 23-27, 12, 13, and 58 show an exemplary fluid sealing and vacuumarrangement for a needle assembly (28, 29). Needle assembly (28, 29) ofthis example includes thumbwheel (36, 206), needle (42), and needle hub(88). Needle hub (88) further includes a mounting portion (48), atelescopic sleeve (90), and a telescopic sleeve spring (92). When aprobe assembly (14, 18, 19) is attached to needle hub (88), telescopicsleeve (90) moves longitudinally against telescopic sleeve spring (92).This movement of telescopic sleeve (90) exposes the fluid sealing andvacuum arrangement mechanisms of needle hub (88) as discussed in moredetail below. When probe assembly (14, 18, 19) is removed from needleassembly (28, 29), sleeve (90) may spring back to a proximal position,under the bias of spring (92).

As shown in FIGS. 23-27, and 58, the fluid sealing and vacuumarrangement mechanisms are components of mounting portion (48) in thisexample. Mounting portion (48) includes a lateral port (94) forcommunicating with lateral lumen (84) of needle (42). A slide cover (96)is provided to avoid fluid leakage from lateral port (94). Slide cover(96) has a pair of thin protruding members (98) that act as springs tobias lateral port (94) in a closed position when probe assembly (14, 18,19) is detached from needle assembly (28, 29). As shown in FIGS. 4, 6,and 58, when probe assembly (14, 18, 19) is attached to needle assembly(28, 29), a vacuum manifold (97, 99, 101) of probe assembly (14, 18, 19)pushes against slide cover (96), which moves distally along mountingportion (48) to expose lateral port (94). Lateral port (94) is shownexposed in FIG. 27. Vacuum manifold (97, 99, 101) is thus in fluidcommunication with lateral lumen (84) of needle (42) via lateral port(94) when probe assembly (14, 18, 19) is coupled with needle assembly(28, 29). As shown in FIGS. 24-27 and 58, vacuum manifold o-rings (108)prevent vacuum loss by providing a seal between vacuum manifold (97, 99,101) and mounting portion (48). It should be understood that laterallumen (84) may be used in accordance with any of the teachings in U.S.Pub. No. 2008/0195066, entitled “Revolving Tissue Sample Holder ForBiopsy Device,” published Aug. 14, 2008, the disclosure of which isincorporated by reference herein, or in any other suitable fashion.

Mounting portion (48) of the present example also includes an axial port(100) for communicating with the axial lumen (82) of needle (42). A cupseal (102) is provided over axial port (100) to prevent fluid leakage. Acutter entry cone (104) may also be provided over cup seal (102). Whenprobe assembly (14, 18, 19) is attached to needle assembly (28, 30) aswill be described in greater detail below, a cutter (106, 107) of probeassembly (14, 18, 19) may enter axial port (100) through the cutterentry cone (104) and the cup seal (102) makes an opening for cutter(106, 107) via a slit (not shown) in cup seal (102). Alternatively, cupseal (102) may be initially formed with or as a puncturable membrane(e.g., without a slit or other opening in it), such that cutter (106,107) breaks the membrane when advanced into needle assembly (28, 30) forthe first time upon coupling of probe assembly (14, 18, 19) with needleassembly (28, 30).

FIGS. 29-32 and 59 show an exemplary fluid sealing and vacuumarrangement mechanism incorporated into another needle assembly (30).Needle assembly (30) of this example includes a thumbwheel (38), needle(44), and needle hub (89). Needle hub (89) includes a mounting portion(60), fixed sleeve (110), and other features for controlling connectionsto axial lumen (82) and lateral lumen (84) of needle (44). For instance,a lateral fluid seal (112) is used for avoiding fluid leakage fromlateral lumen opening (114), while an axial fluid seal assembly (116) isused for avoiding fluid leakage through axial lumen opening (118). Axialfluid seal assembly (116) comprises an o-ring (120) positioned aroundaxial lumen opening (118) of needle (44), and a hollow cap member (122)that is positioned over axial lumen opening (118) and contacts o-ring(120) to create a seal with the needle (44). A sealing member (124) isfitted inside hollow cap member (122), followed by a spacer (126), a cupseal (128), and a cover member (130).

When a probe assembly (14, 18, 19) is attached to needle hub (89), fixedsleeve (110) sits over a vacuum manifold (97, 99, 101) of probe assembly(14, 18, 19). For instance, and as shown in FIG. 59, vacuum manifold(101) may include protruding members (103) that open lateral fluid seal(112) for establishing fluid communication from vacuum manifold (101) tolateral lumen (84) through lateral lumen opening (114). Also, when probeassembly (14, 18, 19) is attached to needle hub (89), cutter (106, 107)passes through a slit (not shown) in cup seal (128) and into axial lumen(82). Again, though, as noted above, cutter (106, 107) may instead formits own opening through cup seal (128), such that cup seal need notnecessarily have a slit or other opening before cutter (106, 107) isadvanced through cup seal (128). As shown in FIGS. 30-32 and 59,manifold o-rings (132) are provided to prevent fluid leakage with thevacuum manifold (101) to needle assembly (30) connection.

FIGS. 35-38 show another exemplary fluid sealing and vacuum arrangementmechanism incorporated into a needle assembly (134). Needle assembly(134) of this example includes a needle hub (136) and modifiedthumbwheel (138). To connect a probe assembly (140) to needle assembly(134), modified thumbwheel (138) has openings (142) that receivedistally extending connecting members (not shown) of probe assembly(140), such as to provide a “snap fit” between probe assembly (140) andneedle assembly (134). For instance, probe assembly (140) may include athumbwheel grip (137) (FIG. 38) that has such distally extendingconnecting members that provide a snap fit with openings (142) ofthumbwheel (138). As shown in FIG. 38, a vacuum manifold (144) of probeassembly (140) fits over a proximal portion of needle hub (136) tofluidly communicate with lateral lumen (84). In particular, needle hub(136) includes a slot (148) for communicating vacuum to lateral lumen(84) from a vacuum line (150) of probe assembly (140) that is coupledwith vacuum manifold (144). Needle hub (136) includes o-rings (146) forpreventing vacuum loss when a probe assembly (140) is attached to needleassembly (134). As is also shown in FIG. 38, coupling probe assembly(140) with needle assembly provides engagement of needle indexing drivegear (157) with needle indexing gear (162), as will be described ingreater detail below.

4. Exemplary Needle Indexing

Another aspect to address with a detachable needle assembly (28, 29, 30,134, 160, 161) design may include indexing of needle (42, 44, 64). Forinstance, needle indexing may include rotation of needle (42, 44, 64) toorient aperture (278) at various angular positions about thelongitudinal axis defined by needle (42, 44, 54). Such multipleorientations may be desirable, by way of example only, to obtain aplurality of tissue samples from a biopsy site, without requiring needle(42, 44, 64) to be removed from the patient during the acquisition ofsuch a plurality of tissue samples. An illustrative example of suchrotation and acquisition of multiple tissue samples is disclosed in U.S.Pat. No. 5,526,822, the disclosure of which is incorporated by referenceherein. Other ways in which multiple tissue samples may be obtained atvarious locations will be apparent to those of ordinary skill in the artin view of the teachings herein.

FIGS. 3-6, 8, 10, 26, and 46 show exemplary indexing mechanismcomponents that incorporate a hexagonal interface for indexing needlessuch as needles (42, 44) shown in FIGS. 22-31. This approach providesremovable coupling between a needle indexing drive assembly and needle(42, 44) itself, to facilitate a detachable needle assembly design. Asshown in FIGS. 3-6, 8, 10 and 46, a needle indexing drive assembly (152)is located on probe assembly (14, 19). Needle indexing drive assembly(152) of this example includes a drive shaft (154) having a hollowhexagonal cross-section. Drive shaft (154) is rotatable relative tomanifold (99).

Needle assembly (28) of FIGS. 22-27, which may be used with a probeassembly (14, 19) having a drive shaft (154) as described above and asshown in FIGS. 3-6 and 9-11, includes a hexagonal-shaped indexingportion (49). When probe assembly (14, 19) is coupled with needleassembly (28), indexing portion (49) of the needle assembly (28) fitswithin the hollow hexagonal space of drive shaft (154). Drive shaft(154) is configured for rotational movement, as described in greaterdetail below, such that when drive shaft (154) rotates, needle assembly(28) rotates concomitantly therewith.

FIGS. 33-36, 38, 48-49, and 58 show other exemplary needle indexingmechanisms that incorporate a gear interface for indexing. This approachprovides removable coupling between a needle indexing drive gear (156,157) and a needle indexing gear (162), to facilitate a detachable needleassembly design. As shown in FIGS. 34 and 38, needle indexing drive gear(156, 157) may be located on probe assembly (158, 140), and may bedriven manually, pneumatically, by motor, or in any suitable fashion. Insome other versions, needle indexing drive gear (159) may be located onholster assembly (20) as shown in FIGS. 13 and 58. As shown in FIGS.33-36, 38, 48-49, and 58, needle assembly (28, 29, 30, 134, 160, 161)includes a needle indexing gear (162). When probe assembly (158, 140,65), and/or probe assembly (18) with holster assembly (20), is connectedto needle assembly (134, 160, 161, 29), needle indexing gear (162)aligns with needle indexing drive gear (156, 157, 159). Needle indexingdrive gear (156, 157, 159) is configured for rotational movement, asdescribed in greater detail below, such that when the needle indexingdrive gear (156, 157, 159) rotates, needle assembly (29, 134, 160, 161)rotates concomitantly therewith.

FIGS. 33-34 further show an exemplary needle assembly (160) having amodified sleeve (164) to allow a needle indexing gear (162) to engage aneedle indexing drive gear (156) of probe assembly (158) whileprotecting the fluid sealing and vacuum arrangement mechanisms describedabove. As shown in FIG. 33, modified sleeve (164) has access openings(166) on the top and bottom to allow a needle indexing drive gear (156)to communicate with needle indexing gear (162).

In particular, and as shown in FIG. 34, needle indexing drive gear (156)of probe assembly (158) may communicate directly with needle indexinggear (162).

In other versions, a needle indexing gear (51) such as the one shown inFIG. 47 engages with a complementary splined socket (not shown) of aneedle indexing drive shaft within a probe that couples with needleportion (29). Gear engagement may thus be internal-external,side-by-side, or of any other suitable type.

Now turning to the modes for actuating the needle indexing drivemechanisms, FIG. 7 shows an exemplary configuration where needleindexing drive gear (168) is partially exposed (e.g., as a manuallyoperable thumbwheel) through the exterior housing of probe assembly(19). In this configuration, an operator may manually rotate needleindexing drive gear (168) to index an attached needle assembly. In oneexample, the partially exposed needle indexing drive gear (168) ispositioned along a central portion of probe assembly (19), as shown inFIG. 7.

By way of example only, needle indexing drive gear (168) may beconfigured and operated in accordance with the teachings of U.S.Non-Provisional patent application Ser. No. [FBT DOCKET NO.0021680.END6473USNP], entitled “TISSUE BIOPSY DEVICE WITH CENTRALTHUMBWHEEL,” filed on even date herewith, the disclosure of which isincorporated by reference herein. For instance, needle indexing drivegear (168) may be analogized to the central thumbwheel described in thatpatent application. Of course, a partially exposed needle indexing drivegear (168) may be provided in any other suitable fashion and in anyother suitable location(s).

Biopsy device (12) of FIGS. 12-21 provides another exemplary mode foractuating a needle indexing drive mechanism. In this example, probeassembly (18) is configured with an indexing knob (170) located on theproximal end of probe assembly (18). Indexing knob (170) is connected toa shaft (172) that has a gear (174) at its distal end, as shown in FIG.15. Gear (174) communicates with another gear (176) (FIGS. 13 and 20-21)that is located in holster assembly (16, 20). Gear (176) in holsterassembly (16, 20) connects to an arrangement of intermediate gears andshafts, which communicate the rotational motion from indexing knob (170)to a needle indexing drive gear (159) of holster assembly (20), as shownin FIGS. 13 and 20. Needle indexing drive gear (159) may communicatedirectly with a needle indexing gear (162) of probe, as shown in FIG.58. Needle indexing gear (162) may rotate unitarily with needle assembly(29), as described herein. Indexing knob (170) may thus be manuallyrotated to rotate needle assembly (29).

Of course, knob (170) may also be similarly coupled with a drive shaft(154) that has a hexagonal needle rotation drive socket, such as inprobe assembly (14) of FIGS. 1-6 or probe assembly (19) of FIGS. 7-11.For instance, needle indexing drive gear (159) may communicateindirectly with a drive shaft (154) through an intermediate drive gear(178) of the probe assembly (14), as shown in FIGS. 3-6. Furthermore,knob (170) may be coupled with drive gear (156) of the example shown inFIG. 34, in a manner similar to that by which knob (170) is coupled withdrive gear (150) of the example shown in FIGS. 12-21.

It should be appreciated that the needle indexing mechanisms disclosedherein may be interchangeable among various biopsy devices (10, 12). Forinstance, those of ordinary skill in the art will understand that abiopsy device (10, 12) having a hexagonal interface indexing mechanismmay be adapted to include a gear interface indexing mechanism, and viceversa. Similarly, those of ordinary skill in the art will understandthat a biopsy device (10, 12) having a probe assembly (14, 18, 19) witha drive shaft (154) for use with a needle assembly (28) having ahexagon-shaped indexing portion (49), may be modified to substitute aneedle indexing drive gear (156, 157, 159) for the drive shaft (154) foruse with a needle assembly (29, 30) having a needle indexing gear (162).Additionally, the various biopsy devices (10, 12) may be adapted for usewith any of the various indexing drive mechanisms disclosed.

It will further be appreciated that needle indexing may be accomplishedwithout the use of a probe assembly (14, 18, 19) and/or holster assembly(16, 20, 21) containing a needle indexing mechanism. For instance,needle assembly (30) of FIGS. 28-32 may be configured for manualindexing by rotating needle assembly (30) when the needle assembly (30)is either detached from a probe assembly (14, 18, 19) or attached to aprobe assembly (14, 18, 19) (e.g., by the operator manually graspingneedle assembly (30) directly by thumbwheel (38), etc.). In addition,any suitable structures other than hexagonal or gear teeth interfacesmay be used to communicate rotation to needle assembly (28, 29, 30, 134,160, 161). Furthermore, some versions may lack needle indexingaltogether.

III. Exemplary Probe Assemblies

Another aspect to consider in a biopsy device having a detachable needlemay be probe assembly design. When considering such probe assemblies,some aspects to address might include the following: (A) probe assemblyengagement with a detachable needle; (B) cutter exposure (i.e., sharpcontrol) before the cutter is inserted into the detachable needle,cutter rotation, and cutter translation; and/or (C) vacuum supply andtissue sample management, among other things.

A. Exemplary Probe Assembly Mounting

1. Exemplary Rocking Probe Locking Cover

FIGS. 39-43 show an exemplary probe locking cover (182) used to engage aprobe assembly (14) with a needle assembly (28). Probe assembly (14) ofthis example includes a casing (180) and locking cover (182). Lockingcover (182) is connected to probe assembly (14) by a pivot pin (184) oncasing (180). Pivot pin (184) is positioned through correspondingopenings (186) in locking cover (182). The attachment of locking cover(182) to probe casing (180) in this way permits some rotation of lockingcover (182) about pivot pin (184). This rotation of locking cover (182)may be used for controlling the engagement and disengagement of probeassembly (14) to needle assembly (28) as discussed in detail below. Ofcourse, pivot pin (184) need not be a single pin passing entirelythrough probe assembly (14), and may simply comprise a pair ofprotrusions that are molded as part of casing (180) and that protrudefrom each side of casing. Furthermore, other suitable structures andrelationships between a locking cover (182) and a probe assembly (14)will be apparent to those of ordinary skill in the art in view of theteachings herein.

Locking cover (182) of the present examples includes an engaging member(188) on its distal end. Engaging member (188) may take the form of atab, protrusion, or any other suitable structure. Engaging member (188)uses a snap connection to attach to an annular recess or groove (190)located on a thumbwheel (36) of needle assembly (28). Springs (192) areincluded on each side of probe casing (180) to provide a rotational biasto locking cover (182) (e.g., urging locking cover (182) to rotate aboutpivot pins (184)). The bias introduced by springs (192) causes engagingmember (188) to engage annular groove (190) in a secure connection, asshown in FIG. 42.

Furthermore, thumbwheel (36) may be provided with a chamfer (196), asshown in FIGS. 42 and 43, to assist in creating the snap connection.When probe assembly (14) is pushed against needle assembly (28), chamfer(196) on thumbwheel (36) pushes engaging member (188) upward, againstthe force of the spring-bias from springs (192), until engaging member(188) reaches annular groove (190). When engaging member (188) reachesannular groove (190), spring-bias from springs (192) forces engagingmember (188) downward into annular groove (190).

It should further be recognized that the annular groove (190) designpermits the snap connection to be secure during needle indexing. Forinstance, annular groove (190) allows needle assembly (28) to be rotatedfor indexing without rotating probe assembly (14). In this example,engaging member (188) slides around within annular groove (190) duringthe indexing of needle assembly (28). Those of ordinary skill in the artwill recognize that there are a variety of ways in which friction may bereduced during rotation, as well as structures and techniques forproviding engagement without affecting rotation.

The locking cover (182) includes spring covers (194) on its proximalportion. To disengage engaging member (188) from annular groove (190), auser pushes downward on spring covers (194), which overcomes thespring-bias on locking cover (182). Such downward pushing on springcovers (194) may cause locking cover (182) to rotate about pivot pins(184). Engaging member (188) of locking cover (182) is then disengagedfrom annular groove (190) of thumbwheel (36), as shown in FIG. 43, andneedle assembly (28) may be removed from the probe assembly (14) (e.g.,by pulling probe assembly (14) longitudinally away from needle assembly(28)).

2. Exemplary Probe Locking Ring

FIGS. 44-47 show an exemplary probe annular ring (198) that may be usedto mount a probe assembly (18, 19) to a needle assembly (29). Probeassembly (18, 19) includes annular ring (198) as well as a locking ring(200). Locking ring (200) of this example comprises locking members(202). To attach probe assembly (18, 19) to needle assembly (29), theuser pushes probe assembly (18, 19) longitudinally against needleassembly (29). Locking members (202) of locking ring (200) engagecorresponding cavities (204) in thumbwheel (206) of needle assembly(29). Locking members (202) include a chamfer (210), which allows forthe proximal edge (208) of thumbwheel (206) to deflect locking members(202) until cavities (204) are reached, at which point locking members(202) will make a snap connection engaging cavities (204). Lockingmembers (202) of this example are resiliently biased to engage cavities(204), while being flexible enough to deflect away from cavities (204)as probe assembly (18, 19) is coupled and decoupled from needle assembly(29).

To disengage probe assembly (18, 19) from needle assembly (29) in thisexample, the user pushes annular ring (198) distally toward needle tip(212). Annular ring (198) is configured to be slidingly engaged withprobe assembly (18, 19). Such sliding engagement may be achieved byincorporating a tapered design of probe's (18, 19) distal end and sizingthe diameter of annular ring (198) to achieve a sliding engagement. Withsuch a sliding engagement, annular ring (198) may be supported on probeassembly (18, 19) by support members or rails, etc. (not shown) on thesides of probe assembly (18, 19). When annular ring (198) is pusheddistally, annular ring (198) contacts a wedge portion (214) on theproximal end of locking members (202). This contact causes the distalportion of the locking members (202) to deflect away from cavities (204)and thereby disengage the thumbwheel (206).

It should further be appreciated that thumbwheel (206) may be configuredwith a single annular cavity or groove (not shown) instead of separatecavities (204). Such an annular cavity or groove may be similar toannular groove (190) of needle assembly (28), described above. Thesingle annular cavity or groove (not shown) may be engaged by lockingmembers (202) to connect the probe assembly (18, 19) to the needleassembly (29). In such a configuration, the single annular cavity orgroove (not shown) may allow needle assembly (29) to be rotated forindexing without rotating probe assembly (18, 19). In this example,locking members (202) may thus slide around the single annular cavity orgroove (not shown) during the indexing of needle assembly (29).

3. Exemplary Probe Locking Ring with Levers

FIG. 50 and FIG. 51 show an exemplary probe annular ring (216) used tomount a probe assembly (218) to a needle assembly (30). Probe assembly(218) of this example includes an annular ring (216), a locking ring(200), and detachment levers (220). Locking ring (200) includes lockingmembers (202) having a chamfer (not shown) on their distal end and awedge portion (214) on their proximal end.

To attach probe assembly (218) to needle assembly (30) in this example,the user pushes probe assembly (218) longitudinally against needleassembly (30). Locking members (202) of locking ring (200) engagecorresponding cavities (222) in thumbwheel (38) of needle assembly (30).Chamfer (210) of locking members (202) allows proximal edge (224) ofthumbwheel (38) to deflect locking members (202) until cavities (222)are reached, at which point locking members (202) will make a snapconnection with cavities (222). Locking members (202) of this exampleare resiliently biased to engage cavities (222), while being flexibleenough to deflect away from cavities (222) as probe assembly (218) iscoupled and decoupled from needle assembly (30).

To disengage probe assembly (218) from needle assembly (30), the userpushes inwardly against pivot members (226) of levers (220). Levers(220) have a chamfer (228) on their distal end. When pivot members (226)are pushed inwardly, the opposite ends of levers (220) rotate away fromthe body of probe assembly (218) about pivot pins (230). This rotationcauses chamfer (228) of levers (220) to drive annular ring (216)distally against wedge portion (214) of locking members (202) on lockingring (200). The contact between annular ring (216) and wedge portion(214) causes the distal portion of locking members (202) to deflect awayfrom cavities (222) and thereby disengage thumbwheel (38). Again,cavities (222) may be substituted with an annular groove or otherfeature or structure.

FIG. 52 shows another exemplary probe assembly (232) having an annularring (234), locking ring (200), and detachment levers (236) for mountingprobe assembly (232) to a needle assembly. Annular ring (234) comprisesproximally extending extension members (238), which pivotally connect todetachment levers (236). Detachment levers (236) further each include anopening (240) that receives a pivot pin (242) of probe assembly (232)for pivotal attachment of detachment levers (236) to probe assembly(232). Locking ring (200) includes locking members (202) having achamfer (210) on their distal end and a wedge portion (214) on theirproximal end.

Attachment of probe assembly (232) to a needle assembly is achieved asdescribed in the previous paragraphs with respect to FIGS. 44-47 and50-51. To detach probe assembly (232) from a needle assembly, a userpulls detachment levers (236) proximally. This causes detachment levers(236) to rotate about pivot pin (242), thereby driving receiving slots(240) and connected extension members (238) distally. The distalmovement of extension members (238) drives annular ring (234) distally,which then pushes against wedge portion (214) of locking members (202).The contact between annular ring (234) and wedge portion (214) causesthe distal portion of locking members (202) to deflect away from alongitudinal axis of the probe assembly (232), thereby disengaging athumbwheel of a needle assembly.

Those of ordinary skill in the art will appreciate that there arevarious other ways in which a probe assembly may selectively couple witha needle assembly. For example, those of ordinary skill in the art willappreciate that the thumbwheel of the needle assembly may berepositioned as a component of the probe assembly, or that thethumbwheel pre-mounted on the probe assembly. In such versions, theattachment of the probe assembly to the needle assembly may beaccomplished as described above in the section discussing needle to thethumbwheel attachment. Other suitable components, features, structures,configurations, and techniques for selectively coupling a probe assemblywith a needle assembly will be apparent to those of ordinary skill inthe art in view of the teachings herein.

It will also be understood by those of ordinary skill in the art thatthe specific probe assemblies and needle assemblies identified above aremerely exemplary and that no single probe assembly as indicated is meantto require a specific needle assembly. Instead, the probe assemblies andneedle assemblies may be adapted such that they may be usedinterchangeably. For instance, needle assembly (28) may be adapted witha thumbwheel design that operates with an annular ring (198) probemounting design instead of a locking cover (182) probe mounting design.Similarly, the probe assembly (18, 19) may be fitted with a lockingcover (182) instead of an annular ring (198) for use with a needleassembly having a thumbwheel (36) with an annular groove (190). Othersuitable variations in probe assembly and needle assembly combinationswill be apparent to those of ordinary skill in the art in view of theteachings herein.

B. Exemplary Cutter Exposure Protection and Cutter Rotation and CutterTranslation Mechanisms

Another aspect to consider with a biopsy probe having a detachableneedle design may be cutter exposure and cutter rotation andtranslation. As discussed previously, a detachable needle design mayinclude a needle assembly that is separate from a probe assembly andholster assembly. The cutter portion of a biopsy device may remain as acomponent of the probe assembly. For instance, the cutter portion may bean elongated hollow tube having a sharp distal end that serves to severthe tissue sample. Because of the sharp nature of the cutter, and withthe cutter extending distally and unexposed relative to a probe assemblybody, it may be important to protect the user from exposure to thecutter when the probe assembly is detached from a needle assembly. Thefollowing paragraphs will discuss several merely exemplary modes ofcutter exposure protection and related cutter rotation and translationmechanisms where appropriate.

1. Exemplary Sliding Cutter Cover

FIGS. 1-6 show an exemplary cutter exposure protection mode involving asliding cutter cover (244). Probe assembly (14) of this example includesa sharp cutter (106) that extends distally from the body of probeassembly (14). This cutter (106) is configured to be inserted into aneedle assembly (28) when probe assembly (14) is coupled with needleassembly (28), as described above. The sharp distal edge of cutter (106)and its distal extension from the body of probe assembly (14) maypresent a hazard to a user of probe assembly (14), which may warrantcovering cutter (106) to some degree when probe assembly (14) is notcoupled with a needle assembly (28) (e.g., when cutter (106) wouldotherwise be exposed). As shown in FIGS. 1-2, sliding cutter cover (244)is configured to retract inside probe assembly (14) when probe assembly(14) is coupled with a needle assembly (28). As shown in FIGS. 3-6,sliding cutter cover (244) is configured to extend distally from probeassembly (14) when probe assembly (14) is not coupled with a needleassembly (28). The extension of sliding cutter cover (244) may protect auser from exposure to the sharp cutter (106). By way of example only,cutter cover (244) may extend from the body of probe assembly (14) to agreater length than the length to which cutter (106) extends from thebody of probe assembly (14).

In operation, elastic strings (246) may be used to control the movementof sliding cutter cover (244). For instance, elastic strings (246) mayconnect to external hooks (248) on a proximal portion of sliding cuttercover (244). Similarly, the opposing ends of elastic strings (246) mayconnect to internal hooks (not shown) on a distal portion of probecasing (180). This arrangement may allow for elastic strings (246) tobias sliding cutter cover (244) to an extended position when probeassembly (14) is not coupled with a needle assembly (28). When probeassembly (14) is coupled with a needle assembly (28), sliding cuttercover (244) is retracted in probe assembly (14) against tension in theelastic strings (246). For instance, the distal edge of an extendedsliding cutter cover (244) may contact the proximal face of thumbwheel(36) when an operator starts to couple probe assembly (14) with needleassembly (28). Needle assembly (28) may be fixed in place by standassembly (24). Accordingly, as probe assembly (14) is moved distally tocouple with needle assembly (28), engagement between the distal edge ofsliding cutter cover (244) and the proximal face of thumbwheel (36) mayurge sliding cutter cover (244) proximally to a retracted positionwithin probe assembly (14).

When needle assembly (28) is detached from probe assembly (14), thetension in elastic strings (246) is released and sliding cutter cover(244) automatically extends back to the extended position to protect thesharp cutter (106). Of course, any other suitable component, structure,feature, or configuration may be used in addition to or in lieu ofelastic strings (246) to bias sliding cutter cover (244) to an extendedposition. By way of example only, one or more springs may be used inaddition to, or in place of, elastic strings (246). Still other suitablecomponents, structures, features, or configurations will be apparent tothose of ordinary skill in the art in view of the teachings herein.

Sliding cutter cover (244) may be designed to have any suitable shapethat may effectively reduce a user's exposure to the sharp cutter (106).For example, as shown in FIGS. 2-6, sliding cutter cover (244) may havean inverted U-shape profile. In other versions, sliding cover (244) mayhave a circular or cylindrical shape, a C-shape, a V-shape, or any othersuitable shape. Other suitable shapes for sliding cutter cover (244)will be apparent to those of ordinary skill in the art in view of theteachings herein.

In terms of cutter rotation and translation associated with a biopsyprobe device having a sliding cutter cover (244) as described above, aconventional cutter rotation and translation mechanism may be used.Suitable cutter rotation and translation mechanisms are described infurther detail in U.S. Pub. No. 2008/0195066, entitled “Revolving TissueSample Holder For Biopsy Device,” published Aug. 14, 2008, thedisclosure of which is incorporated by reference herein; and U.S.Non-Provisional patent application Ser. No. [FBT DOCKET NO.0021680.END6473USNP], entitled “TISSUE BIOPSY DEVICE WITH CENTRALTHUMBWHEEL,” filed on even date herewith, the disclosure of which isincorporated by reference herein. Alternatively, any other suitablemechanism may be used to rotate and/or translate cutter (106).

It should be understood that, the length of cutter (106) may be suchthat, when probe assembly (14) is coupled with needle assembly (28), thedistal end of cutter (106) may be positioned just proximal to (e.g.,very near to yet still proximal to) the proximal edge of aperture (278).When a cutting sequence is initiated, cutter (106) will thus not need totravel far in order to sever tissue protruding through aperture (278).In other words, cutter (106) will not necessarily have to travel thefull longitudinal length of needle assembly (28) in order to reachaperture (278) to sever a tissue sample when a cutting sequence isinitiated. Cutter (106) may thus be effectively “staged” for cuttingimmediately upon coupling of probe assembly (14) with needle assembly(28).

2. Exemplary Telescoping Cutter Cover

FIGS. 7-11 show an exemplary cutter exposure protection mode involvingpartial retraction of cutter (106), along with a telescopic cutter cover(250). When probe assembly (19) is coupled with a needle assembly (29)in this example, telescopic cutter cover (250) retracts inside probeassembly (19) against a compression spring (252). For instance, thedistal edge of an extended telescopic cutter cover (250) may contact theproximal face of thumbwheel (206) when an operator starts to coupleprobe assembly (19) with needle assembly (29). Needle assembly (29) maybe fixed in place by stand assembly (24). Accordingly, as probe assembly(14) is moved distally to couple with needle assembly (29), engagementbetween the distal edge of telescopic cutter cover (250) and theproximal face of thumbwheel (206) may urge telescopic cutter cover (250)proximally to a collapsed or retracted position probe assembly (19).With probe assembly (19) being coupled with needle assembly (29), cutter(106) may partially extend within needle assembly (29) without exposingthe user to sharp cutter (106).

When probe assembly (19) is detached from needle assembly (29),telescopic cutter cover (250) extends from probe assembly (19) under thedistal urging of compression spring (252). Also, cutter (106) ispartially retracted inside the probe assembly (19) by a cuttertranslation and rotation mechanism as discussed further below. Thecombination of partially retracted cutter (106) and extended telescopiccutter cover (250) may protect a user from exposure to the sharp cutter(106) to some degree.

As shown in FIGS. 8-10, compression spring (252) is located in thedistal portion of probe assembly (19). At its distal end, thecompression spring (252) is engaged with the proximal end of telescopiccutter cover (250). The proximal end of compression spring (252) isengaged with probe assembly (19). The configuration of compressionspring (252) provides a spring-bias that extends telescopic cutter cover(250) distally when probe assembly (19) is not coupled with a needleassembly (29). Compression spring (252) nevertheless permits telescopiccutter cover (250) to retract proximally within probe assembly (19) whenprobe assembly (19) is coupled with a needle assembly (29). It will beappreciated that other components may be used to achieve the extensionand retraction of telescopic cutter cover (250). By way of example only,an elastic string configuration may be used as discussed above withrespect to sliding cutter cover (244). Still other suitable components,structures, features, configurations, or techniques for achievingextension and retraction of telescopic cutter cover (250) will beapparent to those of ordinary skill in the art in view of the teachingsherein.

Also as shown in FIGS. 8-11, an external helix (254) provides theability to translate cutter (106) longitudinally within probe assembly(19); while a cutting gear (262) provides the ability to rotate cutter(106) to sever a tissue sample. External helix (254) includes atranslation gear (260) at its proximal end and cutting gear (262) at itsdistal end. Gears (260, 262) are fixedly coupled with external helix(254) in this example, such that gears (260, 262) and external helix(254) rotate unitarily. External helix (254) further includes a track(266) having a fast thread portion (256) and a fine thread portion(258). Fast thread portion (256) has a high pitch to provide for smoothand rapid translation of cutter (106) from its partially retracted stateto its extended state. Fine thread portion (258) has a low pitch toprovide for fine controlled translation of cutter (106) during cuttingaction. A bracket (268) included on external helix (254) is providedwith a pin (270) that fits within track (266). Bracket (268) furtherattaches to cutter (106), and serves as a carriage to translate cutter(106) longitudinally while permitting cutter (106) to rotate relative tobracket (268).

Translation gear (260) is in communication with a drive gear (264),which is exposed by holster assembly (21). As will be described ingreater detail below, holster assembly (21) is operable to rotate drivegear (264). Furthermore, translation gear (260) and drive gear (264) arepositioned and configured such that gears (260, 264) mesh when probeassembly (19) is coupled with holster assembly (21). Rotation of drivegear (264) thus causes corresponding rotation of the translation gear(260), which in turn causes external helix (254) to rotate. As externalhelix (254) rotates, the bracket (268) translates longitudinally due toengagement of pin (270) with track (266). Cutter (106), being attachedto bracket (268), translates longitudinally with bracket (268). Thetranslating movement is greater when bracket (268) travels through fastthread portion (256) of track (266) compared to fine thread portion(258).

Rotation of drive gear (264) also imparts rotation to the cutting gear(262) through cutting gear's (262) connection with external helix (254).An elongated gear (272) is unitarily secured to cutter (106) (e.g., viaovermolding, etc.) in this example. Elongated gear (272) is configuredto engage cutting gear (262) once cutter (106) has translated from itspartially retracted position. In particular, thread portions (256, 258)and elongated gear (272) are sized and configured such that, about whenpin (270) reaches a transition between fast thread portion (256) andfine thread portion (258), cutter (106) has translated distally to alongitudinal position whereby elongated gear (272) engages cutting gear(262). The engagement of cutter gear (262) with elongated gear (272) issuch that rotating cutter gear (262) rotates elongated gear (272),thereby rotating cutter (106), which may aid in severing a tissuesample. Furthermore, the elongated design of elongated gear (272) mayallow for continued rotation as cutter (106) translates through alongitudinal range of motion.

It will therefore be appreciated that, in the present example, bracket(268) is attached to cutter (106) in a way that allows cutter (106) torotate freely while translating longitudinally. For instance, as shownin FIG. 8, bracket (268) may include open clamp members (274) that arepositioned on each side of a blocking member (276) associated withcutter (106). Also, in this configuration, it will be appreciated thatthe placement of the components is such that the fine translatingmovement and rotation of cutter (106) may coincide with the point atwhich cutter (106) reaches the aperture (278) of an attached needleassembly (29). Of course, any other suitable structures, features,components, configurations, and/or techniques may be used to rotateand/or translate cutter (106) to sever a tissue sample.

It will also be appreciated that telescopic cutter cover (250) may bedesigned to have any suitable shape that may effectively reduce a user'sexposure to the sharp cutter (106). For instance, as shown in FIGS.7-10, telescopic cutter cover (250) may have an inverted C-shape. Inother exemplary versions, telescopic cutter cover (250) may have ahollow cylinder shape, a U-shape, a V-shape, or any other suitablecross-sectional shape. Other suitable shapes for telescopic cutter cover(250) will be apparent to those of ordinary skill in the art in view ofthe teachings herein.

In the present example, approximately 60% of the length of cutter (106)is retracted within probe assembly (16) when cutter (106) is in aretracted position; while telescoping cutter cover (250) extends toshield the other 40% of the length of cutter (106), which extendsdistally from probe assembly (19). Of course, any other amount of thelength of cutter (106) may be retracted within probe assembly (16) whencutter (106) is in a retracted position. Similarly, telescoping cuttercover (250) may shield any other suitable length of cutter (106)extending distally from probe assembly (19) when cutter (106) is in aretracted position.

In some variations, telescopic cutter cover (250) is substituted with adesign having multiple telescopic cutter covers (280), as seen in FIG.52. In such an exemplary version, the multiple telescopic cutter covers(280) may comprise concentric hollow cylinders. Such covers (280) may besping-biased distally like telescoping cutter cover (250) describedabove. Still other suitable variations of telescoping cutter cover (250)and covers (280) will be apparent to those of ordinary skill in the artin view of the teachings herein.

3. Exemplary Retractable Cutter

FIGS. 12-19 show an exemplary cutter exposure protection mode involvinga fully retractable cutter (107). To achieve full translation of thecutter (107) and adequate rotation for cutting, probe assembly (18) ofthis example includes an internal helix mechanism (282) that surroundscutter (107). Internal helix mechanism (282) includes a hollow tube(284), a fine thread lead screw (286), a gear (288), a lead screw nut(290), and a cutter driver (292). Hollow tube (284) is rotatable withinprobe assembly (18), and is formed with an interior track (294).Interior track (294) has a helical region (295) and a longitudinalregion (297), which is distal to helical region (295). Cutter driver(292) is fixedly secured to the proximal end of cutter (107) (e.g., byovermolding, etc.), and includes an integral pin (296) that isconfigured to engage interior track (294). Lead screw nut (290) is alsofixedly secured near the proximal end of cutter (107) (e.g., byovermolding, etc.). Cutter driver (292) and lead screw nut (290) thusrotate and translate unitarily with cutter (107) in this example.

A rotating drive gear (298) is exposed by holster assembly (20) in thisexample. As will be described in greater detail below, holster assembly(21) is operable to rotate drive gear (264). Drive gear (298) and gear(288) of internal helix mechanism (282) are positioned and configuredsuch that gears (288, 298) mesh when probe assembly (18) is coupled withholster assembly (20). Rotation of drive gear (298) thus causescorresponding rotation of gear (288). Gear (288) is fixedly coupled withhollow tube (284) in this example, such that rotation of drive gear(298) also causes rotation of hollow tube (284) when probe assembly (18)is coupled with holster assembly (20). As tube (284) is rotated, cutter(107) translates longitudinally in this example. In particular, pin(296) of cutter driver (292) travels in interior track (294) of tube(284) as tube (284) is rotated. This longitudinal translation of cutterdriver (292) causes corresponding translation of cutter (107), as cutterdriver (292) is fixedly secured to cutter (107) in this example.Retraction or extension of the cutter (107) relative to the remainder ofprobe assembly (18) may thus be determined by the direction of rotation.It will be appreciated by those of ordinary skill in the art that thepitch of track (294) may be adjusted to provide greater or lessertranslational movement per unit of rotation. Furthermore, it will beappreciated that the pitch of track (294) may be variable through thelength of hollow tube (284) (e.g., a fast pitch region and a fine pitchregion, etc.).

As shown, fine thread lead screw (286) is positioned longitudinallyadjacent to and distal to hollow tube (284). Fine thread lead screw(286) is fixed within probe assembly (18), and includes a leaf spring(300), which biases a pin (302) toward cutter (107). Cutter (107) has alongitudinal slot (304) along a portion of its length. In particular,longitudinal slot begins near the distal end of cutter (107) andterminates at a selected proximal point on cutter (107). By way ofexample only, cutter (107) may have a stepped configuration such that aportion having slot (304) is of a greater outer diameter than theportion without slot (304). Thus, slot (304) terminates at or near alongitudinal position where cutter (107) outer diameter transitions.

Longitudinal slot (304) is configured to receive pin (302). Engagementof pin (302) in slot (304) prevents cutter (107) from rotating as pin(296) of cutter driver (292) travels in interior track (294) of tube(284). For instance, in the first stages of extending cutter (107) (orthe later stages of retracting cutter (107)), as hollow tube (284)rotates and cutter (107) translates longitudinally, pivot pin (302)travels in slot (304), and prevents cutter (107) from rotating whilepermitting translational movement of cutter (107). Of course, any othersuitable structures, components, features, configurations, or techniquesmay be used to restrict rotation of cutter (107) during stages ofextending cutter (107) from probe assembly (18) and/or retracting cutter(107) into probe assembly (18).

As cutter (107) reaches an extended position (e.g., when the distal endof cutter (107) nears aperture (278) of attached needle assembly (29)),longitudinal slot (304) of the cutter (107) terminates and pivot pin(302) no longer restricts rotational movement of cutter (107).Furthermore, lead screw nut (290) engages fine thread lead screw (286)when cutter (107) reaches a sufficiently distally extended position. Atthis point, pin (296) of the cutter driver (292) reaches the transitionfrom helical region (295) of interior track (294) to longitudinal region(297) of interior track (294). With pivot pin (302) no longerrestricting rotational movement of cutter (107), and with pin (296) ofcutter driver (292) at longitudinal region (297) of interior track(294), further rotational motion communicated to hollow tube (284) bygear (288) cause cutter (107) to rotate in this example. Furthermore,with cutter (107) at such an extended longitudinal position, lead screwnut (290) internally engages fine thread lead screw (286). Lead screwnut (290) and fine thread lead screw (286) have complementary threads,such that rotation of cutter (107) (and, hence, rotation of lead screwnut (290)) causes longitudinal translation of cutter (107). Longitudinalregion (297) of interior track (294) permits pin (296) (and, hence,cutter (107)) to translate relative to hollow tube (284) during suchengagement between threads of lead screw nut (290) and fine thread leadscrew (286). Cutter (107) may thus rotate and translate simultaneouslyas hollow tube (284) is rotated throughout this longitudinal positioningof cutter (107), to sever a tissue sample from tissue protruding throughaperture (278). After severing the tissue sample, retraction of cutter(107) may occur in reverse order and begins by imparting rotation tohollow tube (284) in the reverse direction.

An encoder gear (299) is also secured to hollow tube (284), such thatencoder gear (299) rotates unitarily with hollow tube (284). Encodergear (299) is configured to mesh with a complementary encoder gear (301)exposed by holster (20), when probe assembly (18) is coupled withholster assembly (20). Encoder gear (301) is coupled with an encoder(303) located within holster (20). Encoder (303) may thus be used totrack the longitudinal position and/or rotation speed, etc., of cutter(107). Suitable encoders and ways in which encoder (303) may be used aredisclosed in U.S. Non-Provisional patent application Ser. No. [FBTDOCKET NO. 0021680.END6473USNP], entitled “TISSUE BIOPSY DEVICE WITHCENTRAL THUMBWHEEL,” filed on even date herewith, the disclosure ofwhich is incorporated by reference herein. Of course, encoder (303) andassociated components may be omitted, if desired.

C. Exemplary Hybrid Detachable Needle

In some settings, it may be desirable to have a first portion of abiopsy device needle provided as an integral component of the biopsydevice, with a second portion of the needle being provided as a separatetargeting cannula. For instance, FIGS. 53-56 show an exemplary partialneedle (306) that may be used with a targeting cannula (308) and cutter(not shown), where it might be desirable to eliminate certain fluidsealing and detachable features of an MRI biopsy device such as thosedescribed above. In this example, cannula (308) may has an integraltissue piercing tip (310) as shown, which may be constructed of ceramicor any other suitable material. Cannula (308) also has a transverseaperture (312) near its distal end. In some versions, tip (310) may formthe upper half of cannula (308) that is distal of aperture (312). Thismay be advantageous where tip (310) is formed of a ceramic material thatis harder than the cutter (not shown) so skiving of the cannula materialdoes not occur. Of course, tip (310) may be formed of any other desiredmaterial.

Cannula (308) also includes a dual lumen portion (314) in its distalregion. Dual lumen portion (314) may be achieved by including a dividingmember (316) within cannula (308) in the distal region. Dividing member(316) partially extends longitudinally within cannula (308), proximallyterminating at a proximal edge (319). Dividing member (316) thus createsan upper lumen (315) and a lower lumen (317). The portion of cannula(308) without dividing member (316) defines a single lumen portion(318). Dividing member (316) includes openings (320) that provide fluidcommunication between upper lumen (315) and lower lumen (317). Also, asshown in FIGS. 54 and 57, the outer portion of cannula (308), alsoincludes a plurality of external openings (321). By way of example only,external openings (321) may be configured and used in accordance withthe teachings of U.S. Pub. No. 2007/0032742, entitled “Biopsy Devicewith Vacuum Assisted Bleeding Control,” published Feb. 8, 2007, thedisclosure of which is incorporated by reference herein. Of course, aswith other components described herein, external openings (321) aremerely optional.

In the present example, a partial needle (306) extends distally from aprobe (not shown). By way of example only, the probe may otherwise beconfigured in accordance with any of the teachings herein; any of theteachings of U.S. Pub. No. 2008/0195066, entitled “Revolving TissueSample Holder For Biopsy Device,” published Aug. 14, 2008, thedisclosure of which is incorporated by reference herein; or any of theteachings of U.S. Non-Provisional patent application Ser. No. [FBTDOCKET NO. 0021680.END6473USNP], entitled “TISSUE BIOPSY DEVICE WITHCENTRAL THUMBWHEEL,” filed on even date herewith, the disclosure ofwhich is incorporated by reference herein. Alternatively, the probe mayhave any other suitable configuration.

Partial needle (306) of the present example has a shovel end (322).Shovel end (322) has an upper distal edge (323), a tongue (325), and alower distal edge (327) at the distal end of tongue (325). Tongue (325)has a plurality of openings (328) formed therethrough. Partial needle(306) also defines an upper lumen (329) and a lower lumen (334), whichterminates at a lower lumen distal edge (333). Upper lumen (229) andlower lumen (334) together define a dual lumen region (324) of partialneedle (306); while upper lumen (229) extends distally past lower lumendistal edge (333) to form a single lumen region (326) of partial needle(306).

As shown in FIG. 57, partial needle (306) of this example is configuredto fit within cannula (308). In particular, lower distal edge (327) ofshovel end (322) abuts the rear face of tip (310); while lower lumendistal edge (333) abuts proximal edge (319) of dividing member (316).Upper lumen (315) of cannula (308) thus unifies with upper lumen (329)of partial needle (306). Similarly, lower lumen (317) of cannula (308)thus unifies with lower lumen (334) of partial needle (306). Inaddition, openings (328) of tongue (328) align with openings (320) ofdividing member (316), providing fluid communication between upperlumens (315, 329) and lower lumens (317, 334). Upper distal edge (323)also aligns with proximal edge (313) of aperture (312). Partial needle(306) and cannula (308) thus together form an assembly similar toneedles (42, 44, 64) described herein. For instance, a vacuum may bedrawn through lower lumens (317, 334) to pull tissue through aperture(312). A cutter (not shown) may then be advanced and rotated throughupper lumens (315, 329) to sever a sample from such tissue; and thesevered tissue sample may be communicated proximally through the lumenof the cutter while a vacuum is drawn through the cutter lumen and whilelower lumens (317, 334) are vented.

In operation, cannula (308) may be positioned using any suitableguidance technique (e.g., MRI imaging). Cannula (308) may have an bluntobturator inserted therein (e.g., to “close off” aperture (312), etc.),and cannula (308) with obturator may be inserted into a patient'sbreast. After positioned, the obturator may be removed. At this stage,some tissue may naturally prolapse or otherwise protrude into aperture(312), even without a vacuum applied. A probe (not shown)—equipped withpartial needle (306) and cutter (not shown)—may then be inserted intothe positioned cannula (308) (e.g., until lower distal edge (327) ofshovel end (322) abuts the rear face of tip (310)). The configuration ofshovel end (322) may reduce any likelihood that partial needle (306)will move or otherwise interfere with any tissue that is naturallyprolapsing or otherwise protruding into aperture (312) as partial needle(306) is inserted into cannula (308). Vacuum may then be induced inlower lumens (317, 334) to draw tissue into aperture (312). The cutter(not shown) may then be translated and rotated through upper lumens(315, 329) to sever the tissue sample. The severed tissue sample maythen be transported through the lumen of the cutter to a tissue samplecontainer (not shown), such as by inducing a vacuum in the cutter lumenwhile venting lower lumens (317, 334).

The foregoing is just one example of how a partial needle (306) may beconfigured relative to a targeting cannula (308). It should beunderstood that partial needle (306) and targeting cannula (308) mayeach be configured in a variety of other ways, and that partial needle(306) and targeting cannula (308) may have a variety of otherrelationships with each other. Suitable variations of partial needle(306) and targeting cannula (308) and their relationships will beapparent to those of ordinary skill in the art in view of the teachingsherein.

D. Exemplary Vacuum Delivery and Tissue Sample Holding

Each probe assembly (14, 18, 19) discussed herein includes vacuumdelivery and tissue sample holding. As noted above, biopsy devices (10,12) described herein function to capture tissue samples, sever thetissue samples from the targeted tissue, and transport the tissuesamples to a tissue sample holder.

In terms of vacuum delivery, vacuum may be delivered to a lateral lumen(84) in needle assembly (28, 29, 30, 134, 160, 161) as well as to anaxial lumen defined by cutter (106, 107). The vacuum induced in laterallumen (84) may aid in capturing the tissue sample for biopsy, such as bydrawing tissue into aperture (278). The vacuum provided to the axiallumen in cutter (106, 107) may aid in transporting the severed tissuesample from the interior of the cutter to a tissue sample container(500). Various ways in which vacuum delivery and other fluidcommunication may be provided to and within any biopsy device (10, 12)described herein are disclosed in U.S. Pub. No. 2008/0195066, entitled“Revolving Tissue Sample Holder For Biopsy Device,” published Aug. 14,2008, the disclosure of which is incorporated by reference herein.

In terms of tissue sample containers (500), examples of such containers(500) are shown in FIGS. 1-10, 12-15, and 52. By way of example only,such containers (500) may include a rotatable manifold (not shown) and aplurality of tissue sample compartments (not shown) that may besuccessively indexed to the lumen of cutter (106, 107). For instance,the manifold may provide fluid communication to the lumen of cutter(106, 107) via a tissue sample compartment, and such fluid communicationmay be used to communicate a vacuum to draw a severed tissue samplethrough the lumen of cutter (106, 107) and into whichever tissue samplecompartment is indexed with the lumen of cutter (106, 107). By way ofexample only, tissue sample container (500) may be configured and usedin accordance with any of the teachings of U.S. Pub. No. 2008/0195066,entitled “Revolving Tissue Sample Holder For Biopsy Device,” publishedAug. 14, 2008, the disclosure of which is incorporated by referenceherein. Alternatively, tissue sample container (500) may be configuredin accordance with any of the teachings of U.S. Non-Provisional patentapplication Ser. No. [FBT DOCKET NO. 0021680.END6471USNP], entitled“BIOPSY DEVICE WITH DISCRETE TISSUE CHAMBERS,” filed on even dateherewith, the disclosure of which is incorporated by reference herein.Of course, any other suitable structures or configurations for tissuesample container (500) may be used.

To the extent that tissue sample container (500) includes a rotatableportion to successively index discrete tissue sample compartments withthe lumen of cutter (106, 107), there are a variety of mechanisms andfeatures that may be used to rotate and otherwise operate such arotatable portion. By way of example only, tissue sample container (500)may be rotatable in accordance with any of the teachings of U.S. Pub.No. 2008/0195066, entitled “Revolving Tissue Sample Holder For BiopsyDevice,” published Aug. 14, 2008, the disclosure of which isincorporated by reference herein. Alternatively, tissue sample container(500) may be rotatable in accordance with any of the teachings of U.S.Non-Provisional patent application Ser. No. [FBT DOCKET NO.0021680.END6465USNP], entitled “MECHANICAL TISSUE SAMPLE HOLDER INDEXINGDEVICE,” filed on even date herewith, the disclosure of which isincorporated by reference herein. Alternatively, tissue sample container(500) may be rotatable in accordance with any of the teachings of U.S.Non-Provisional patent application Ser. No. [FBT DOCKET NO.0021680.END6473USNP], entitled “TISSUE BIOPSY DEVICE WITH CENTRALTHUMBWHEEL,” filed on even date herewith, the disclosure of which isincorporated by reference herein. Of course, tissue sample container(500) may be rotatable in any other suitable fashion.

Furthermore, those of ordinary skill in the art will appreciate that atissue sample container (500) may be omitted altogether if desired. Atissue sample container (500) may also be mounted on another assembly ofa biopsy device (10, 12) instead of probe assembly (14, 18, 19) (e.g.,to holster assembly (16, 20, 21)). Alternatively, tissue samplecontainer (500) may be located separate from biopsy device (10, 12),such as by being remotely connected by a vacuum line that transports thetissue sample. Still other ways in which a tissue sample container maybe incorporated into a biopsy device (10, 12) will be apparent to thoseof ordinary skill in the art in view of the teachings herein.

IV. Exemplary Holster Assemblies

As described briefly above and shown in FIGS. 1-14, 20-21, and 52various holster assemblies (16, 20, 21) may be used with probeassemblies (14, 18, 19). For instance, holster assembly (16) coupledwith probe assembly (14) in FIGS. 1-6 provides a cutter drive mechanismand a needle indexing mechanism. Similarly, holster assembly (20)coupled with probe assembly (18) in FIGS. 12-14, 20, and 21 alsoprovides a cutter drive mechanism and a needle indexing mechanism. Inanother exemplary holster assembly (21), shown in FIGS. 7-11, a cutterdrive mechanism may be provided, but a needle indexing mechanism may beprovided separate from holster assembly (21). In these exemplary holsterassemblies (16, 20, 21), the cutter drive and needle indexing mechanismsmay be provided through a series of shafts and gears which may be drivenby a motor (e.g., electric or pneumatic) or driven manually.

By way of example only, holster assemblies (16, 20, 21) may beconfigured in accordance with the teachings of U.S. Pub. No.2008/0195066, entitled “Revolving Tissue Sample Holder For BiopsyDevice,” published Aug. 14, 2008, the disclosure of which isincorporated by reference herein. Alternatively, holster assemblies (16,20, 21) may be configured in accordance with the teachings of U.S.Non-Provisional patent application Ser. No. [FBT DOCKET NO.0021680.END6473USNP], entitled “TISSUE BIOPSY DEVICE WITH CENTRALTHUMBWHEEL,” filed on even date herewith, the disclosure of which isincorporated by reference herein. Alternatively, holster assemblies (16,20, 21) may have any other suitable structures, components, features,configurations, functionalities, and methods of operation. Suitablestructures, components, features, configurations, functionalities, andmethods of operation will be apparent to those of ordinary skill in theart in view of the teachings herein.

Embodiments of the present invention have application in conventionalendoscopic and open surgical instrumentation as well as application inrobotic-assisted surgery.

Embodiments of the devices disclosed herein can be designed to bedisposed of after a single use, or they can be designed to be usedmultiple times. Embodiments may, in either or both cases, bereconditioned for reuse after at least one use. Reconditioning mayinclude any combination of the steps of disassembly of the device,followed by cleaning or replacement of particular pieces, and subsequentreassembly. In particular, embodiments of the device may bedisassembled, and any number of the particular pieces or parts of thedevice may be selectively replaced or removed in any combination. Uponcleaning and/or replacement of particular parts, embodiments of thedevice may be reassembled for subsequent use either at a reconditioningfacility, or by a surgical team immediately prior to a surgicalprocedure. Those skilled in the art will appreciate that reconditioningof a device may utilize a variety of techniques for disassembly,cleaning/replacement, and reassembly. Use of such techniques, and theresulting reconditioned device, are all within the scope of the presentapplication.

By way of example only, embodiments described herein may be processedbefore surgery. First, a new or used instrument may be obtained and ifnecessary cleaned. The instrument may then be sterilized. In onesterilization technique, the instrument is placed in a closed and sealedcontainer, such as a plastic or TYVEK bag. The container and instrumentmay then be placed in a field of radiation that can penetrate thecontainer, such as gamma radiation, x-rays, or high-energy electrons.The radiation may kill bacteria on the instrument and in the container.The sterilized instrument may then be stored in the sterile container.The sealed container may keep the instrument sterile until it is openedin a medical facility. A device may also be sterilized using any othertechnique known in the art, including but not limited to beta or gammaradiation, ethylene oxide, or steam.

Having shown and described various embodiments of the present invention,further adaptations of the methods and systems described herein may beaccomplished by appropriate modifications by one of ordinary skill inthe art without departing from the scope of the present invention.Several of such potential modifications have been mentioned, and otherswill be apparent to those skilled in the art. For instance, theexamples, embodiments, geometries, materials, dimensions, ratios, steps,and the like discussed above are illustrative and are not required.Accordingly, the scope of the present invention should be considered interms of the following claims and is understood not to be limited to thedetails of structure and operation shown and described in thespecification and drawings.

1. A biopsy probe for use with a detachable needle, wherein the biopsyprobe comprises: (a) a body comprising a distal portion and proximalportion, wherein the body comprises an opening at an end of the distalportion; (b) a cutter comprising a hollow tube having a sharp distal endoperable to sever tissue, wherein the cutter is positioned within theprobe and extends from the opening of the body, wherein the cutter isoperable to translate longitudinally relative to the body; and (c) acover comprising a distal portion and proximal portion, wherein thecover is operable to translate relative to the body to shield the cutterwhen the biopsy probe is detached from the needle.
 2. The biopsy probeof claim 1, further comprising one or more connecting members, whereinthe connecting members comprise a first end portion and a second endportion, wherein the first end portion couples with the proximal portionof the cover and the second end portion couples with the distal portionof the body.
 3. The biopsy probe of claim 2, wherein the cover comprisesone or more fastening members to secure the first end portion of the oneor more connecting members to the cover.
 4. The biopsy probe of claim 3,wherein the fastening members comprise hooks that are configured toengage the connecting members.
 5. The biopsy probe of claim 2, whereinthe body comprises one or more fastening members to secure the secondend portion of the one or more connecting members to the body.
 6. Thebiopsy probe of claim 2, wherein the connecting members comprise elasticstrings.
 7. The biopsy probe of claim 1, wherein the cutter extends fromthe body an amount that positions the cutter at the proximal end of atissue aperture in the needle upon attaching the biopsy probe to theneedle.
 8. The biopsy probe of claim 1, wherein the cover is made from atransparent material.
 9. The biopsy probe of claim 1, further comprisinga detachable needle, wherein the detachable needle is configured toremovably couple with the body, wherein the detachable needle comprisesa probe engagement member configured to engage the cover upon couplingof the body with the needle, wherein the detachable needle defines alumen configured to receive the cutter.
 10. The biopsy probe of claim 1,wherein the cover comprises an opening configured to permit a user toobserve the cutter.
 11. The biopsy probe of claim 10, wherein the coverhas a “U” shaped cross section.
 12. The biopsy probe of claim 1, whereinthe cover is configured to selectively retract inside the body.
 13. Thebiopsy probe of claim 1, further comprising a resilient member biased tourge the cover distally relative to the body.
 14. The biopsy probe ofclaim 1, wherein the cutter extends distally from the body for a firstlength, wherein the cover extends distally from the body for a secondlength, wherein the second length is longer than the first length. 15.The biopsy probe of claim 1, further comprising a needle engagementmechanism, wherein the needle engagement mechanism is operable toselectively secure the body relative to the needle.
 16. The biopsy probeof claim 15, wherein the needle engagement mechanism comprises a rockingcover having an engagement tab configured to selectively engage a recessin the needle.
 17. The biopsy probe of claim 16, further comprising aresilient member biased to urge the engagement tab into engagement withthe recess in the needle.
 18. A biopsy device with a detachable needle,wherein the biopsy device comprises: (a) a needle, wherein the needlecomprises a probe body engagement member, wherein the needle defines alumen; (b) a probe body comprising a distal portion and proximalportion, wherein the probe body comprises a needle engagement mechanism,wherein the needle engagement mechanism is operable to selectivelyengage the probe body engagement member of the needle to selectivelysecure the probe body relative to the needle; (c) a cutter extendingdistally from the probe body, wherein the cutter is configured to bereceived in the lumen defined by the needle, wherein the cutter isoperable to translate longitudinally relative to the probe body; and (d)a cover, wherein the cover is movable from an extended position to aretracted position, wherein the cover shields the cutter when the coveris in the extended position, wherein the cover is moved to the retractedposition when the probe body is coupled with the needle.
 19. A method ofprotecting a user from an exposed cutter of a biopsy device, the methodcomprising: (a) providing a detachable needle having a tissue piercingtip and an axial lumen; (b) providing a biopsy probe, wherein the biopsyprobe comprises: (i) a body comprising a distal portion and proximalportion; (ii) a cutter extending distally from the body, wherein thecutter is operable to translate longitudinally relative to the body; and(iii) a cover comprising a distal portion and proximal portion, whereinthe cover extends distally from the body to shield the cutter, whereinthe cover is operable to translate relative to the body; and (c)coupling the biopsy probe with the detachable needle, wherein the act ofcoupling comprises: (i) aligning the cutter with the axial lumen of thedetachable needle; and (ii) coupling the distal portion of the body withthe detachable needle, wherein the cover is simultaneously retractedrelative to the body in response to the act of coupling the distalportion of the body with the detachable needle.
 20. The method of claim19, further comprising decoupling the body from the detachable needle,wherein cover is simultaneously advanced relative to the body inresponse to the act of decoupling the body from the detachable needle.